Fulvestrant as Maintenance Therapy After First-line Chemotherapy in HER2 - Postmenopausal MBC Patients (FUMANCE)
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|ClinicalTrials.gov Identifier: NCT02383030|
Recruitment Status : Unknown
Verified June 2016 by Consorzio Oncotech.
Recruitment status was: Recruiting
First Posted : March 9, 2015
Last Update Posted : June 15, 2016
Breast cancer is one of the most prevalent cancers among women, and represents 20 - 25% of all female cancers. Despite earlier diagnosis and improvement in adjuvant therapies, some patients will present metastatic recurrence.
Treatment of breast cancer is determined by the extent of the disease. Early or localized breast cancer is treated by a combination of surgery and radiotherapy. Adjuvant systemic therapy, consisting of chemotherapy and/or endocrine therapy, in tumors deemed hormone responsive, can prolong the disease-free interval and improve overall survival. However, approximately 30% to 40% of patients with early breast cancer will ultimately relapse, with either local recurrence or distant metastases, and require further systemic treatment for advanced disease.
Since breast cancer that recurs or progresses after initial treatment is considered incurable, the therapy options available for advanced disease are concerned with disease control and palliation of symptoms.
Hormonal therapy has become the treatment of choice in postmenopausal women with hormone sensitive breast cancer. Even though the treatment of advanced breast cancer in postmenopausal women has improved with the introduction of agents such as aromatase inhibitors, these agents still have limitations, and disease management continues to be sub-optimal. The use of systemic therapies such as hormonal therapy, chemotherapy or new biological treatment is to reduce tumour masses, improve survival and preserve quality of life. Whatever the initial efficacy of the treatment undertaken in metastatic setting, almost every patient will relapse. The main goal is to improve progression free survival (PFS). To achieve this, the type of chemotherapy, the optimal duration of chemotherapy, the benefit of maintenance chemotherapy, the benefit of maintenance hormonal treatment are debatable.
|Condition or disease||Intervention/treatment||Phase|
|Metastatic Breast Cancer||Drug: Fulvestrant||Phase 3|
The search for prognostic and predictive factors that could influence the survival of patients treated for metastatic breast cancer has already been the subject of several studies. It seems that 2 components in the natural outcome of tumors must be considered. The first category is related to the primary characteristics such as initial histological grade, hormonal receptor status. The second category is linked to the metastatic characteristics: proliferation index reflected by the length of disease-free interval, type and number of metastatic sites involved. On the other hand, some prognostic factors are linked to the treatments undertaken, stressing their impact on the natural outcome of the disease: type of hormonotherapy, type of chemotherapy, type of response achieved by treatment.
The impact of some factors remains debatable, such the duration of treatment. The optimal duration of chemotherapy in patients who respond or have stable disease is not identified.
Definitively, the major limit to the use of prolonged regimens of chemotherapy is related to their toxicity, all the more so as they are cumulative (cardiac toxicity of anthracyclins, neurologic toxicity of taxanes, haematological cumulative toxicities with any chemotherapy…). The proposition to give hormonal treatment to prolong therapy in hormonal-positive tumors is another possible option. In the literature, data focused on this strategy are rare.
One can object that the choice of patient/tumor characteristics for who would or would not receive the maintenance hormonal therapy was not random, or controlled in any way. This may have led to a selection of better prognosis patients. Investigators cannot know whether they are observing natural history or impacting it in such a trial. Nevertheless the major impact obtained by maintenance hormonal treatment after the first line chemotherapy might indicate that this strategy should be recommended in patients with an ER or PgR positive tumor. Based on the amplitude of the benefit observed, it may be ethically debatable to conduct a prospective randomized study. Moreover, randomized trials which assess the benefit of a new chemotherapy regimen should allow the possibility to give maintenance hormonal treatment.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||156 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Randomized Phase III Study of Fulvestrant as Maintenance Therapy After First-line Chemotherapy in HER2 Negative Postmenopausal Metastatic Breast Cancer Patients|
|Study Start Date :||November 2015|
|Estimated Primary Completion Date :||September 2017|
|Estimated Study Completion Date :||December 2017|
In Arm A maintenance Fulvestrant will be given until disease progression, unacceptable toxicity or refused of patient to the treatment.
After randomization patients will receive (Arm A, experimental Arm) fulvestrant as the following schedule: 500 mg i.m. on Days 0, 14, 28 followed by fulvestrant 500 mg im given every 28 days until progression disease. Study will start after 42 days from the last cycle of chemotherapy
Other Name: Faslodex
No Intervention: No intervention
Patients will be randomized to receive fulvestrant (experimental arm) or no treatment
- Maintenance-progression-free survival (mPFS) [ Time Frame: 36 months ]Time between the date of randomization and the date of progression or death, whichever occurs first
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02383030
|Contact: Alessandra Fabi, MDfirstname.lastname@example.org|
|Contact: Elena Abrami, BDemail@example.com|
|Study Chair:||Francesco Cognetti||Regina Elena National Cancer Institute Via Elio Chianesi 53, 00144 Rome, Italy|